Screw Catch Mechanism for PFO Occluder and Method of Use

ABSTRACT

Devices, delivery systems and delivery techniques for an occlusion device for the closure of physical anomalies, such as an atrial septal defect, a patent foramen ovale (PFO), and other septal and vascular defects are described. The devices, delivery systems and delivery techniques relate particularly to, but are not limited to, a patent foramen ovale (PFO) occluder made from a polymer tube, specifically, a petal-shaped occluder. In certain embodiments, the catch system includes a catch member with a screw catch mechanism for connecting to the occluder. A delivery system for use with the catch member includes a component for rotating the catch member relative to the occluder to engage the screw catch mechanism.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional application of U.S. application Ser.No. 11/729,045 filed Mar. 28, 2007, now pending; which claims thebenefit under 35 USC §119(e) to U.S. Application Ser. No. 60/787,987filed Mar. 31, 2006, now expired. The disclosure of each of the priorapplications is considered part of and is incorporated by reference inthe disclosure of this application.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates generally to occlusion devices for the closure ofphysical anomalies, such as an atrial septal defect, a patent foramenovale, and other septal and vascular defects. In particular, thisinvention relates to a catch mechanism to maintain the occluder in thedeployed configuration. The invention also relates to delivery systemsand mechanisms for such devices.

2. Background Information

A patent foramen ovale (PFO), illustrated in FIG. 1, is a persistent,one-way, usually flap-like opening in the wall between the right atrium11 and left atrium 13 of the heart 10. Because left atrial (LA) pressureis normally higher than right atrial (RA) pressure, the flap usuallystays closed. Under certain conditions, however, right atrial pressurecan exceed left atrial pressure, creating the possibility that bloodcould pass from the right atrium 11 to the left atrium 13 and bloodclots could enter the systemic circulation. It is desirable that thiscircumstance be eliminated.

The foramen ovale serves a desired purpose when a fetus is gestating.Because blood is oxygenated through the umbilical cord, and not throughthe developing lungs, the circulatory system of the fetal heart allowsthe blood to flow through the foramen ovale as a physiologic conduit forright-to-left shunting. After birth, with the establishment of pulmonarycirculation, the increased left atrial blood flow and pressure resultsin functional closure of the foramen ovale. This functional closure issubsequently followed by anatomical closure of the two overlappinglayers of tissue: septum primum 14 and septum secundum 16. However, aPFO has been shown to persist in a number of adults.

The presence of a PFO is generally considered to have no therapeuticconsequence in otherwise healthy adults. Paradoxical embolism via a PFOis considered in the diagnosis for patients who have suffered a strokeor transient ischemic attack (TIA) in the presence of a PFO and withoutanother identified cause of ischemic stroke. While there is currently nodefinitive proof of a cause-effect relationship, many studies haveconfirmed a strong association between the presence of a PFO and therisk for paradoxical embolism or stroke. In addition, there issignificant evidence that patients with a PFO who have had a cerebralvascular event are at increased risk for future, recurrentcerebrovascular events. The presence of a PFO has also been linked toanother condition, chronic migraine headaches. While researchers arestill working on finding an explanation, PFO closure has been shown toeliminate or significantly reduce migraine headaches in many patients.

In certain cases, such as when anticoagulation is contraindicated,surgery may be necessary or desirable to close a PFO. The surgery wouldtypically include suturing a PFO closed by attaching septum secundum toseptum primum. This sutured attachment can be accomplished using eitheran interrupted or a continuous stitch and is a common way a surgeonshuts a PFO under direct visualization.

Umbrella devices and a variety of other similar mechanical closuredevices, developed initially for percutaneous closure of atrial septaldefects (ASDs), have been used in some instances to close PFOs. Thesedevices potentially allow patients to avoid the side effects oftenassociated with anticoagulation therapies and the risks of invasivesurgery. However, umbrella devices and the like that are designed forASDs are not optimally suited for use as PFO closure devices.

Currently available septal closure devices present drawbacks, includingtechnically complex implantation procedures. Additionally, there aresignificant complications due to thrombus, fractures of the components,conduction system disturbances, perforations of heart tissue, andresidual leaks. Many devices have a high septal profile and includelarge masses of foreign material, which may lead to unfavorable bodyadaptation of a device. Given that ASD devices are designed to occludeholes, many lack anatomic conformability to the flap-like anatomy ofPFOs. Thus, when inserting an ASD device to close a PFO, the narrowopening and the thin flap may form impediments to proper deployment.Even if an occlusive seal is formed, the device may be deployed in theheart on an angle, leaving some components insecurely seated against theseptum and, thereby, risking thrombus formation due to hemodynamicdisturbances. Finally, some septal closure devices are complex tomanufacture, which may result in inconsistent product performance.

Various devices and delivery systems have been developed to deliveroccluders and other medical devices through body lumens. Some deliverysystems of the prior art are used to deliver devices that readily expandto a delivered configuration when removed from the delivery system.Other occluders do not readily expand into a deployed configuration andtechniques are used to change the configuration of the device into thedeployed configuration. In the latter case, once an occluder isdelivered to the desired delivery site and deployed, the occluder musthave a catch system that keeps the device in the deployed configuration.

The devices and techniques disclosed herein are designed to addressthese and other deficiencies of prior art septal closure devices andtechniques for delivering and retrieving such devices.

SUMMARY OF THE INVENTION

This description discloses a delivery system and technique(s) fordelivering an implant into a desired location within the body andsecuring the device in the deployed configuration. The device(s) relateparticularly to, but are not limited to, a septal occluder made from apolymer tube. The occluder includes a first side adapted to be disposedon one side of the septal tissue and a second side adapted to bedisposed on the opposite side of the septal tissue. The first and secondsides are adapted to occlude the aperture upon deployment of the deviceat its intended delivery location. The delivery technique, in additionto use with septal occluders, could be applied to other medical devices,such as other expandable devices constructed from an underlying tubularstructure.

In one embodiment, the present invention provides a catch system thatmaintains the configuration of an occluder once it has been deployed. Inone aspect, the catch system includes a catch member having a threadedoutside surface at the proximal end that can be threadably attached tothe proximal side of the occluder. The distal end of the catch memberincludes a flange that can apply a proximal force on the distal end ofthe occluder. A delivery wire having a threaded outside surface at thedistal end can be threadably attached to the proximal or distal end ofthe catch member, so that by pulling the delivery wire in the proximaldirection, a proximal force is applied to the catch member and thedistal end of the occluder. The delivery system also includes a deliverycatheter that can be threadably attached to the proximal end of theoccluder and can be used to maintain the position thereof. Duringdeployment, the delivery wire can be used to pull the distal end of theoccluder in the proximal direction, thereby converting the occluder intoan expanded profile, deployed configuration. An inner catheter having akey that fits inside a slot at the proximal end of the catch member isprovided to apply an axial twisting force upon the catch member. Usingthe inner catheter, the proximal ends of the catch member and theoccluder can be threadably attached or detached.

Before deployment, various components of the delivery system, catchsystem and the occluder in a reduced profile configuration can beconnected and placed inside a delivery sheath. After moving the distalend of the delivery sheath past an aperture in the septum, the deliverysheath can be retracted. The delivery wire can then be used to convertthe occluder to the expanded profile deployed configuration to occludethe aperture. The inner catheter can then be used to attach the proximalends of the catch member and the occluder so that the occluder maintainsthe deployed configuration. After attachment, the delivery catheter canbe detached from the occluder and removed. The occluder can later beretrieved if desired.

In another aspect, the catch system includes a catch member having athreaded outside surface at the proximal end that can be threadablyattached to the proximal side of the occluder. The distal end of thecatch member includes a flange that can apply a proximal force on thedistal end of the occluder. A delivery wire forms a loop around thedistal end of the catch member. Two apertures may be used to loop thedelivery wire around the distal end. The delivery wire could be apolymeric material or metallic material. In some embodiments it could benitinol. In some embodiments, a delivery wire that can translate axialforce in a pushing direction may be advantageous. The delivery systemalso includes a delivery catheter that can be threadably attached to theproximal end of the occluder and can be used to maintain the positionthereof. During deployment, the delivery wire can be used to pull thedistal end of the occluder in the proximal direction, thereby convertingthe occluder into an expanded profile, deployed configuration. An innercatheter having a slot at the distal end that fits a key at the proximalend of the catch member is provided to apply an axial twisting forceupon the catch member. Using the inner catheter, the proximal ends ofthe catch member and the occluder can be threadably attached ordetached.

According to at least some embodiments, the occluder is formed from atube. According to some embodiments, the tube includes a materialselected from the group consisting of metals, shape memory materials,alloys, polymers, bioabsorbable polymers, and combinations thereof. Inparticular embodiments, the tube includes a shape memory polymer. Inparticular embodiments, the tube includes nitinol. In some embodiments,the tube is formed by rolling a flat piece of material into a tubularform. According to some embodiments, the occluder is formed by cuttingthe tube. In other embodiments, the occluder is formed from a pluralityof filaments, aligned in a tubular arrangement and bonded at selectedlocations. The occluder is placed in its deployment configuration byreducing the axial length of the device.

These and other aspects and embodiments of the invention are illustratedand described below.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic representation of a human heart including variousseptal defects.

FIG. 2 illustrates a deployed occluder according to an aspect of theinvention.

FIG. 3 illustrates introduction of the occluder in a human heart using adelivery system in accordance with an aspect of the invention.

FIG. 4 illustrates a detail view of a delivery catheter in a heart withits tip approaching a patent foramen ovale between the left atrium andright atrium.

FIGS. 5-8 illustrate an occluder according to the present invention in asequence between a reduced profile delivery configuration (FIG. 5) andan expanded profile deployed configuration (FIG. 8).

FIG. 9 is an exploded view of components of a delivery system for anoccluder in accordance with an embodiment of the present invention.

FIGS. 10 and 11 are end views of the catch member and inner catheter ofFIG. 9 respectively, as seen along lines 10-10 and 11-11.

FIG. 12 is a axial cross-sectional detail view of a delivery system withan occluder in accordance with an embodiment of the present inventionwithin a delivery catheter.

FIGS. 13 and 14 are partial cross-sectional views of a delivery systemfor an occluder of the present invention.

FIG. 15 is an exploded view of components of a delivery system andoccluder in accordance with another embodiment of the present invention.

FIGS. 16 and 17 are end views of the catch member and inner catheter ofFIG. 15 respectively, as seen along lines 16-15 and 17-17.

FIGS. 18A-18C are cross-sectional schematic drawings of anotherembodiment of the invention with a wire connection between the catchmember and the delivery wire.

FIG. 19 illustrates a schematic view of a catch member according toanother embodiment of the invention.

FIG. 20 illustrates a schematic view of another embodiment of theinvention.

DETAILED DESCRIPTION OF THE INVENTION

In various aspects, the present invention provides devices,delivery/retrieval systems and techniques for delivering such devicesintended to occlude an aperture within body tissue. In particular and asdescribed in detail below, the described occluder may be used forclosing an ASD, ventricular septal defect (VSD) or PFO in the atrialseptum of a heart. Although the embodiments are described with referenceto an ASD, VSD or PFO, one skilled in the art will recognize that thedevice and methods of the present invention may be used to treat otheranatomical conditions. As such, the invention should not be consideredlimited in applicability to any particular anatomical condition. Inaddition, the systems and methods for delivery and retrieval, and forcatching a device in a deployed state, that are aspects of the presentinvention may also be used in connection with other types of devicesbesides an occluder, in particular, devices having tubular profiles.

FIG. 1 illustrates a human heart 10, having a right atrium 11 and a leftatrium 13 and including various anatomical apertures 18 a and 18 b. Theatrial septum 12 includes septum primum 14 and septum secundum 16. Theanatomy of the septum 12 varies widely within the population. In somepeople, septum primum 14 extends to and overlaps with septum secundum16. The septum primum 14 may be quite thin. When the anatomical aperture18 a is present, blood could travel through the anatomical aperture 18 abetween septum primum 14 and septum secundum 16 (referred to as “the PFOtunnel”). Additionally or alternatively, blood could travel through theanatomical aperture 18 b (referred to as ASD).

In this application, “distal” refers to the direction away from acatheter insertion location and “proximal” refers to the directionnearer the insertion location. Additionally, the term “deliveryconfiguration” refers to the configuration of a device, such as anoccluder, when it has a reduced profile in a delivery catheter. The term“deployed configuration” refers to the configuration of the device, suchas an occluder, when it has an expanded profile, such as deployed fromthe catheter at the desired implantation location.

FIG. 2 illustrates an exemplary occluder with which systems andtechniques disclosed herein may be used. An occluder 70, for example, isillustrated as deployed in the septum 12 of a heart. The occluder 70operates to close an aperture in the septum by covering the sides of theaperture. The reference numerals used to identify components of thedescribed embodiment are disposed on multiple figures where thecomponent is illustrated. The reference numerals are intended tofacilitate an overall understanding of the invention and therelationship between components illustrated in different figures.

The embodiment described in conjunction with FIGS. 5-8 has somesimilarities to the device disclosed in or can be used in conjunctionwith catch mechanisms and delivery/retrieval systems and techniquesdisclosed in U.S. patent application Ser. No. 10/890,784 entitledTubular Patent Foramen Ovale (PFO) Closure Device with Catch Systemfiled Jul. 14, 2004; U.S. patent application Ser. No. 11/395,718entitled Tubular Patent Foramen Ovale (PFO) Closure Device with CatchSystem filed Mar. 31, 2006; U.S. patent application Ser. No. 11/384,635entitled Catch Member for PFO Occluder filed Mar. 20, 2006; U.S. patentapplication Ser. No. 11/235,661 entitled Occluder Device DoubleSecurement System for Delivery/Recovery of Such Occluder Device filedSep. 26, 2005; U.S. patent application Ser. No. 11/121,833 entitledCatching Mechanisms for Tubular Septal Occluder filed May 4, 2005; U.S.Patent Application No. 60/787, 988 entitled Deformable Flap CatchMechanism for Occluder Device filed Mar. 31, 2006; U.S. patentapplication Ser. No. 11/644,373 entitled Catch Members for OccluderDevices filed Dec. 21, 2006; and U.S. patent application Ser. No.11/728,694 entitled Patent Foramen Ovale (PFO) Closure Device withLinearly Elongating Petals filed Mar. 27, 2007, all of which have thesame assignee as the present application and are incorporated herein byreference in their entirety. These incorporated documents describe someways in which a device can be formed by making cuts or slits in a tubeand compressing the ends, and how to deliver such a device.

As shown in FIGS. 5-8, the occluder 70 is formed from a tube (which canbe extruded or rolled), or alternately from a plurality of filamentsthat have been bonded together, that forms distal petals 72 produced byslits 74 in the distal portion of tube according to the cutting patternshown in FIG. 5. As shown in FIG. 6, the distal portion 20 of the tubeincludes eight slits 74 that form eight extended segments of the tubethat form the distal loops or petals 72. As apparent from the figures,the slits extend the entire distance of the distal portion of the tubebetween central tube 78 and distal end 76 so that the loops of the samecross-section are formed. Upon application of force F_(d) to distal end76, extended segments defined by slits 74 bow and twist outward to formdistal petals 72 in distal side of the occluder 70. The movement of thesegments during deployment is such that the segments may rotate in anorthogonal plane relative to the axis of the device. Central tube 78 maybe constrained during the application of force F_(d), or any combinationof forces sufficient to reduce the axial length of the occluder may beapplied. One end of each of distal petals 72 originates from centraltube 78, while the other end originates from distal end 76 (FIGS. 6 and7). Proximal petals 82 may be formed in the proximal portion 40, asshown in FIGS. 6-8, by making slits 84 between central tube 78 andproximal end 86, using the same cutting pattern described above andapplying force F_(p) or a combination of forces sufficient to reduce theaxial length of the tube allowing slits 84 to bow and twist outward toform proximal petals 82 in proximal portion 40 of the occluder 70. Oneend of each of distal petals 82 originates from central tube 78, whilethe other end originates from proximal end 86.

The tube(s) or filaments forming occluder 70 may be formed from abiocompatible metal or polymer. In at least some embodiments, theoccluder 70 is formed of a bioabsorbable polymer, or a shape memorypolymer. Shape memory polymers can be advantageous so that the structureof the device assists in pressing the PFO tunnel closed. In otherembodiments, the occluder 70 is formed of a biocompatible metal, such asa shape memory alloy (e.g., nitinol). The thermal shape memory and/orsuperelastic properties of shape memory polymers and alloys permit theoccluder 70 to resume and maintain its intended shape in vivo despitebeing distorted during the delivery process. Alternatively, oradditionally, the occluder 70 may be formed of a bioabsorbable metal,such as iron, magnesium, or combinations of these and similar materials.Exemplary bioabsorbable polymers include polyhydroxyalkanoatecompositions, for example poly-4-hydroxybutyrate (P4HB) compositions,disclosed in U.S. Pat. No. 6,610,764, entitled PolyhydroxyalkanoateCompositions Having Controlled Degradation Rate and U.S. Pat. No.6,548,569, entitled Medical Devices and Applications ofPolyhydroxyalkanoate Polymers, both of which are incorporated byreference in their entirety.

The cross-sectional shape of the tube may be circular or polygonal, forexample square, or hexagonal. The slits 74, 84 may be disposed on theface of the polygon (i.e., the flat part) or on the intersection of thefaces.

The tube can be injection molded, extruded, or constructed of a sheet ofmaterial and rolled into a tube. The sheet of material could be a singleply sheet or multiple ply. The slits that form the segments could be cutor stamped into the sheet prior to rolling the sheet into a tube toconnect the ends to form an enclosed cross section. Various geometricalcross sections are possible including circular, square, hexagonal andoctagonal and the joint could be at the vertex or along the flat of awall if the cross section is of a particular geometry. Variousattachment techniques could be used to join the ends of the sheet toform a tube, including welding, heat adhesives, non-heat adhesives andother joining techniques suitable for in vivo application.

The petal configuration, illustrated in FIG. 8, is the deployedconfiguration. The occluder 70 can be secured in the deployedconfiguration by a catch system that holds the ends of the tubetogether, certain embodiments of which are described below.

The transformable design of occluder 70 enables occluder 70 to bedelivered in a reduced profile, delivery configuration and to beconverted readily, i.e., by reducing the axial length, in place to theexpanded profile deployed configuration. Moreover, the conversion canreadily be effected by forcing distal end 76 and proximal end 86 to movetoward each other. For example, distal portion 20 and proximal portion40 of occluder 70 may be deployed in separate steps, or both distalportion 20 and proximal portion 40 of occluder 70 may be exposed (e.g.,out of the delivery catheter) prior to engaging the catch system anddeployed together as the catch element is engaged. Use of the termsdistal and proximal portion 20 and 40, respectively, include the loopsor other geometries and configurations that are formed on the distal andproximal sides, respectively.

Occluder 70 may be made in any one of several ways. Slits 74 and 84 maybe cut such that tube bends into its intended configuration followingdeployment in vivo. Specifically, slits 74 and 84 may be cut to producesegments 72 and 82 (as illustrated in FIGS. 5, 6) of a thickness thatfacilitates the bending and formation of loops 72 and 82 (as illustratedin FIGS. 7, 8) upon the application offerees F_(d) and/or F_(p) duringdeployment. The segments 72, 82 that form the loops are referenced withthe same reference numeral. As an alternative, or additionally, a tubeformed of a shape memory material may be preformed into its intendedconfiguration ex vivo so that it will recover its preformed shape oncedeployed in vivo. According to at least some embodiments, thispreforming technique produces more reliable deployment and bending ofoccluder 70 in vivo. An intermediate approach may also be used: tube maybe only slightly preformed ex vivo such that it is predisposed to bendinto its intended shape in vivo upon application offerees F_(d) and/orF_(p). An occluder formed from filaments can similarly be preformed exvivo.

FIG. 2 shows a deployed occluder 70 in a human heart with a catch member50 engaged (much of the catch member is obscured by the central tube ofthe occluder). The term “catch system” describes the components orportions/aspects of a device that secures the occluder in the deployedconfiguration; it may be a single piece or a group of connected orassembled pieces. In embodiments described herein, a catch systemincludes a catch member substantially disposed within an axial passageof the occluder that engages with the ends of the occluder to hold theoccluder in the deployed configuration. The axial passage can beradially central in some embodiments. The catch member is described inmore detail below. This particular type of occluder 70 and deliverysequences are described for purposes of illustration and explanation; ofcourse, other types of occluders can be deployed using the catch systemsdescribed herein.

The catch member 50, as illustrated, is disposed in a radially centrallocation in the occluder 70 and is schematically illustrated as aseparate piece than the occluder 70. In a preferred embodiment, thedistal end of the catch member includes a flange 92 (shown in FIGS. 6-8)that rests against, but not fixed to, the distal end 76 of the occluder70. When the catch member 50 is pulled in the proximal direction, theflange 92 applies a force F_(d) to the distal end 76 of the occluder 70and moves it in the proximal direction. In general, references to“occluder 70” herein may be inclusive of catch member 50, depending onthe context, for example, unless separately listed or otherwise stated.

One end of the occluder, preferably the proximal end 86 of the occluder70, is able to move with respect to the catch member 50 (and especiallythe catch system provided thereby) so that the distal and proximalpetals 72 and 82 can move from the delivery configuration to thedeployed configuration. When the proximal end of the catch member 50 isconnected with the proximal end 86 of the occluder 70, the occluder issecured in its deployed configuration.

FIG. 3 illustrates the insertion of an occluder in a human subject 122using a delivery assembly 124 in accordance with an aspect of thedisclosure. A portion of delivery assembly 124, including an occluderand a delivery mechanism for the occluder, which can be externallymanipulated by a clinician, is inserted into the subject through anincision point 126. The distal end of the delivery assembly is advancedtoward and into the heart 10 until the distal end is in proximity to thedefect to be closed, as seen in FIG. 4.

One embodiment of a delivery system 250 of the present invention willnow be described with reference to FIGS. 9-12. As used herein, whenconnected to an occluder and/or catch member, the term “delivery system”may include those components. FIG. 9 is an exploded perspective view ofthe components of the delivery system 250 including a catch member 50that can be disposed in the radially central portion of the occluder 70.The illustrated system 250 further includes a delivery catheter 172 withits distal end 178 for holding the proximal end 86 of the occluder 70during its delivery, deployment, and retrieval, an inner catheter 168slidably disposed within the delivery catheter 172 with a key 166 at itsdistal end, and a delivery wire 164 slidably disposed within the innercatheter 168 designated to connect with the catch member 50 with athreaded portion 162 at its distal end. The catch member 50 includesflange 92 at the distal end. The flange 92 rests against the distal end76 of the occluder 70, so that when a force F_(d) is applied to catchmember 50, the distal end of the occluder 70 moves along with catchmember 50 in the proximal direction. The distal end of the catch member50 is allowed to freely rotate relative to the occluder 70, for reasonsthat are made clear as the operation of the device is described below.Typically the catch member 50 has an axial length of about 5-30 mm and adiameter of approximately 0.5-3 mm. The axial length of the catch member50 is related to the axial length of the occluder in the deployedconfiguration. Although the catch member 50 is illustrated as a circularcylinder, a variety of cross-sectional shapes can be used effectively.

According to one embodiment, catch member 50 is made of any metal orpolymer. In another embodiment, catch member 50 is made of biocompatiblemetal or polymer. In an alternative embodiment, catch member 50 is madeof bioabsorbable or shape memory material.

In a specific embodiment, catch member 50 is made of shape memorymaterial (e.g., nitinol). The thermal shape memory and/or superelasticproperties of shape memory polymers and alloys permit the catch member50 to resume and maintain its intended shape in vivo despite beingdistorted during the delivery and/or deployment process.

In one embodiment, catch member 50 is made of a bioabsorbable material.Exemplary bioabsorbable materials include polymers, such aspolyhydroxyalkanoate compositions, for example poly-4-hydroxybutyrate(P4HB) compositions, disclosed in U.S. Pat. No. 6,610,764, entitledPolyhydroxyalkanoate Compositions Having Controlled Degradation Rate andU.S. Pat. No. 6,548,569, entitled Medical Devices and Applications ofPolyhydroxyalkanoate Polymers, both of which are incorporated byreference in their entirety.

The proximal end 160 of the catch member 50 includes external threads152 that cooperate with internal threads 154 of the proximal end 86 ofthe occluder 70. When engaged, the threaded connection formed by threads152 and 154 operates to hold the occluder 70 in the deployedconfiguration. The connection can be released by unthreading the catchmember 50 from the proximal end of the occluder 70. Once the connectionis released, the occluder 70 can collapse into its deliveryconfiguration and be retrieved.

In the illustrated embodiment, The proximal end 160 of the catch member50 also includes internal threads 158 and a slot 156 (shown in dashedlines) disposed at the radial center of the catch member 50. In otherembodiments, the internal threads 158 can be disposed anywhere along thelength of catch member 50, i.e., at the proximal or distal ends or morecentrally. The internal threads 158 are designed to cooperate withexternal threads 162 of the distal end of the delivery wire 164. Whenengaged, the threaded connection formed by threads 158 and 162 allows aforce F_(d) to be applied to the catch member 50 when the delivery wire164 is pulled in the proximal direction. To release the delivery wireafter the deployment of the occluder 70, the threaded connection betweenthreads 158 and 162 is disengaged.

In addition to the threaded portion 154 at the proximal end 86 of theoccluder 70 to secure, the catch member 50, the occluder can includeadditional internal threads at the center joint or connection member 78.For example, as illustrated, the connection member 78 may have threads79 that can cooperate with the threads 152 on the catch member 50 tosecure the occluder in an intermediate position. Of course, as with allthe embodiments, the number of threads can vary. That is, more or fewerthreads can be provided than illustrated in the exemplary embodiment.

Other mechanisms for connecting the delivery wire 164 and catheter 168are also possible. Although FIG. 9 shows the delivery wire 164 designedto connect with the catch member 50 by a threaded connection, theconnection between the delivery wire 164 and the catch member 50 can beany other suitable mechanism as described in, for example, U.S. patentapplication Ser. No. 11/235,661, incorporated by reference herein in itsentirety. In specific embodiments, the delivery wire 164 can also beconnected with the catch member 50 by any other suitable means,including various types of wire or other long flexible material. Forease of reference, the delivery wire is intended to include all long,flexible materials that are suitable for the intended purpose described.In some embodiments, it may be advantageous to have the delivery wire beable to translate an axial pushing force. If a sufficiently thinmaterial is used, the delivery wire 164 can be cut to release thedelivery wire 164 after the deployment of the occluder 70. Otherembodiments are described below.

The delivery wire 164 is disposed inside inner catheter 168 and canfreely slide or rotate relative to the inner catheter 168. The innercatheter 168 is slidably disposed within the delivery catheter 172. Theinner catheter 168 can also extend inside the radially central portionof occluder 70 and can freely rotate or slide relative to the occluder70. Disposed at the distal end 170 of the inner catheter 168 is a key166 that can be inserted into the slot 156 at the proximal end 160 ofthe catch member 50. When inserted, the key 166 of the inner catheter168 fits the slot 156 at the proximal end 160 of the catch member 50, sothat by rotating the inner catheter 168, the catch member 50 can berotated. Hence, upon inserting the key 166 of the inner catheter 168 tothe slot 156 at the proximal end 160 of the catch member 50, the innercatheter 168 can be used to threadably engage or disengage the externalthreads 152 at the proximal end 160 of the catch member 50 with internalthreads 154 of the occluder 70.

FIGS. 10 and 11 are end views of the catch member and inner catheter ofthe delivery system 250 illustrated in FIG. 9, as seen along lines 10-10and 11-11 respectively. Although the cross-section of the key 166 of theinner catheter 168 and the slot 156 at the proximal end 160 of the catchmember 50 are shown as squares, a variety of cross-sectional shapes canbe used effectively.

The delivery system includes a delivery catheter 172 for holding theproximal end 86 of the occluder 70 during the deployment or retrieval ofthe occluder 70. The distal end 178 of the delivery catheter 172includes internal threads 174 that cooperate with external threads 176at the proximal end 86 of the occluder. The delivery catheter 172 can bethreadably connected to the occluder 70 using threads 174 and 176. Whenapplying a force F_(d) to the distal end 76 of the occluder 70, thedelivery catheter 172 can hold the position of the proximal end 86 ofthe occluder 70, or apply a force F_(p) in the opposite direction offorce F_(d), so that the axial length of the occluder 70 is reduced andthe occluder 70 is transformed from the delivery configuration into thedeployed configuration. Once the occluder 70 is deployed, the deliverycatheter 172 can be disconnected from the occluder 70 and removed.

Although FIG. 9 shows the delivery catheter 172 designed to connect withthe occluder 70 by a threaded connection, the connection between thedelivery catheter 172 and the occluder can be any other suitablemechanism as described in, for example, U.S. patent application Ser. No.11/235,661, incorporated by reference herein in its entirety.

FIG. 12 is a cross-sectional detail view of the delivery system, catchmember 50 and the occluder 70 illustrated in FIGS. 9-11 within adelivery sheath 200. As shown, the delivery catheter 172 is connectedwith the proximal end 86 of the occluder 70. The inner catheter 168 isin contact with the proximal end 160 of the catch member 50, with thekey 166 at the distal end inserted into the slot 156 at the proximal end160 of the catch member 50. The delivery wire 164 is disposed inside theinner catheter 168 and is shown in phantom lines. The delivery wire 164is attached to the proximal end 160 of the catch member 50. The flange92 at the distal end of the catch member 50 is in contact with thedistal end 76 of the occluder 70. The occluder 70 is in a reducedprofile, delivery configuration so that it fits within the deliverysheath 200. Using the delivery sheath 200, the occluder 70 and the catchmember 50 can be inserted into or retrieved from a human subject asillustrated in FIG. 3.

As illustrated in FIG. 12, various components of the delivery system,the catch member 50 and the occluder 70 can be connected and placedinside the delivery sheath 200 before deployment. After moving thedistal end of the delivery sheath 200 past an aperture in the septum,the delivery sheath 200 can be removed, exposing the occluder 70. Thedelivery wire 164 and the delivery catheter 172 can then be used toconvert the occluder 70 from the delivery configuration to the expandedprofile, deployed configuration to occlude the aperture. The innercatheter 168 and delivery wire 164 can then be used to connect andengage the proximal ends 160 of the catch member 50 and proximal ends 86of the occluder 70 so that the occluder 70 maintains the deployedconfiguration. Then, the delivery catheter 172 and inner catheter 168can be detached from the occluder 70 and removed. With the delivery wire164 still connected to the catch member 50, the deployment of theoccluder 70 can now be assessed. If deployment of the occluder 70 is notsatisfactory, the occluder 70 can be retrieved. Upon satisfaction withthe deployment of the occluder 70, the delivery wire 164 can be removed.In an alternate sequence, the delivery wire 164 and inner catheter 168can be detached from occluder 70 first. The position can be assessedwith the delivery catheter 172 in place. The delivery catheter 172 canthen be removed.

If retrieval is needed, the inner catheter 168 can be disposed insidethe delivery catheter 172, which can be disposed inside the deliverysheath 200 and advanced together into the heart. In addition, thedelivery wire 164 can be disposed inside the inner catheter 168 andinserted together with the inner catheter 168. The delivery catheter 172engages the proximal end 86 of the occluder 70, and the delivery wire164 engages the proximal end 160 of the catch member 50. The innercatheter 168 and delivery wire 164 is used to rotate the catch member 50to disengage its proximal end 160 from the proximal end 86 of theoccluder 70. After the occluder 70 returns to its reduced profile,delivery configuration, the occluder 70 and the catch member 50 can bewithdrawn together with the delivery sheath 200.

FIGS. 13 and 14 are partial cross-sectional views of a delivery assembly124 in accordance with an aspect of the disclosure. Delivery assembly124 includes an occluder 70 and a catch member 50 at the distal end. Asshown in FIG. 13, delivery assembly 124 has four coaxial components,which make up the delivery system 250, disposed next to the occluder 70,which are the delivery wire 164, the inner catheter 168, the deliverycatheter 172, and the delivery sheath 200. As FIG. 14 illustrates, thedelivery wire 164, the inner catheter 168, the delivery catheter 172,and the delivery sheath 200 can all freely slide and rotate with respectto each other. The motion of these components can be controlled by anapparatus 202 disposed at the proximal end of the delivery assembly 124.Apparatus 202 can be manipulated externally from the body by aclinician.

FIG. 14 illustrates the types of movement possible at the proximal endof the delivery system that can deploy the occluder 70 with a catchmember 50 according to an embodiment of the present invention. Asillustrated in FIG. 14, one embodiment of the invention can be deliveredby the use of a delivery system that can be manipulated in several axial(back and forth) and rotational (around an axis) directions.Particularly, the delivery sheath 200 can be moved axially by movement Dand (optionally) rotationally by the movement H. Directional arrows atthe proximal side illustrate the direction of movement an operator wouldeffect to move in the same direction at the distal side. The proximalportion is on the upper part of FIG. 14 and the distal side is on thelower portion of FIG. 14. The delivery catheter 172 can be moved axiallyby movement A and rotationally by movement E. The inner catheter 168 canbe moved in the axial direction by movement B and rotationally bymovement G. Finally, the delivery wire 164 can be moved axially bymovement C and rotationally by movement F. Of course, variouscombinations of movements are possible and desirable, for example duringdelivery of the occluder 70 to the desired delivery site through theblood vessels, all the components will be moved together.

FIG. 15 is an expanded view of a delivery system 300 in accordance withanother embodiment of the present invention. Similar to the deliverysystem 250 illustrated in FIGS. 9-12, this delivery system 300 includesa catch member 256 that can be disposed in the radially central portionof the occluder 70, a delivery catheter 252 with its distal end 178 forholding the proximal end 86 of the occluder 70 during its delivery,deployment, and retrieval, an inner catheter 258 slidably disposedwithin the delivery catheter 252 with a slot 274 at its distal end, anda delivery wire 260 slidably disposed within the inner catheter 258designed to connect with the catch member 256. The proximal end 254 ofthe catch member 256 includes external threads 264 that cooperate withinternal threads 266 of the proximal end 86 of the occluder 70. Whenengaged, the threaded connection 264 and 266 operate to hold theoccluder 70 in the deployed configuration. When the proximal end 254 ofthe catch member 256 and the proximal end 86 of the occluder 70 aredisengaged, the occluder 70 can collapse into its reduced profile,delivery configuration and be retrieved. The catch member 256 includes aflange 262 at the distal end that rests against the distal end 76 of theoccluder 70.

Different from the delivery system 250 shown in FIG. 9, the deliverywire 260 engages the catch member 256 by forming a loop around thedistal end of the catch member 256. As illustrated, two apertures may beformed within the catch member 256 to secure the delivery wire 260. Asillustrated in FIG. 18A, in this embodiment, the catch member 256includes an axial passageway 268 sufficient to allow the wire to bedisposed within. The distal end of the catch member 256 has twoapertures 270 which communicate with the axial passageway. The deliverywire 260 extends distally through the first aperture, bends, and returnsthrough the second aperture. During occluder delivery, the distal end ofthe delivery wire 260 extends to a general proximal direction. Bypulling the delivery wire 260 in the proximal direction, a force F_(d)can be applied to the catch member 256 and the distal end 76 of theoccluder 70. After the deployment of the occluder 70, the delivery wire260 can be removed.

An inner catheter 258 is disposed inside the central portion of theoccluder 70 and can freely rotate or slide relative to the occluder 70.The distal end of the inner catheter 258 includes a slot 274 that fits akey 272 disposed at the proximal end of the catch member 256. Using theinner catheter 258, the catch member 256 can therefore be rotated toengage the proximal end 86 of the occluder 70 locking the occluder inthe deployed configuration. This delivery system 300 can be used todeploy occluder 70 in generally the same manner as the delivery systemdescribed in connection with FIGS. 9-12.

FIGS. 16 and 17 are end views of the catch member and inner catheter ofthe delivery system 300 as seen along lines 16-16 and 17-17, of FIG. 15,respectively. The cross-sectional shape of the key 272 at the proximalend of the catch member 256 and the slot 274 of the inner catheter 258are not limited to what is illustrated in FIGS. 15-17; various othercross-sectional shapes can be used effectively.

FIGS. 18A-18C illustrate the function of the delivery wire 260 duringoccluder delivery and its removal after occluder deployment. Asillustrated in detail cross-sectional view, with similar referencenumerals being given an “a”. For example, the catch member is “50 a”. Inthis embodiment a delivery wire 260 is provided that can transmit apushing force along its axial length so that a pushing force applied atthe proximal end of the delivery wire 260 can push the delivery wire 260distally. The delivery wire 260 is disposed in an axial passageway 352in the catch member 50 a. The delivery wire 260 extends distally throughthe first aperture 354, bends, and returns through the second aperture356. During occluder deployment, catch member 50 a extends proximally bya pulling force T_(tensilewire), and the delivery wire 260 remains inplace in the aperture as illustrated in FIG. 18A. To remove deliverywire 260, as illustrated in FIG. 18B, a force T_(pushwire) is applied,the delivery wire 260 extends distally. Distal end of the delivery wire260 is then freed from the second aperture, and therefore the deliverywire 260 is disconnected with the catch member 50 a. Then, a forceT_(pullwire) is applied, the delivery wire 260 is removed as illustratedin FIG. 18C. In some embodiments, the delivery wire material could be304SS stainless steel flat wire or nitinol.

FIG. 19 illustrates another embodiment of a catch member 50 b that canbe used with various embodiments of the invention described herein. Inthis embodiment, the occluder 70 is designated with numbers consistentwith previous embodiments. A catch member 50 b includes a flange orridge 360 at the proximal side of the distal end 76 in addition to adistal flange 92 b. According to this embodiment, the flanges 360 and 92b are able to restrain the axial movement of the distal end 76 of theoccluder with respect to catch member 50 b. The catch member 50 b may beallowed to rotate with respect to the occluder or not depending on theconfiguration of other parts of the catch system. In a preferredembodiment, the ridge 360 is disposed adjacent to the distal end of thecatch member 50 b. The distance between the ridge 360 and the distalflange 92 b is approximately equal to the axial length of the tubulardistal end 76 of the occluder 70. The ridge 360 has a radial sizeapproximately equal to the distal flange 92 b, but the size could besmaller or larger in various embodiments. The center ridge 360facilitates pushing of the distal end 76 if retrieval of the occluder 70is desired. The center ridge 360 thus can be used to collapse theoccluder 70.

It will be understood that the threads 152 and 154, 174 and 176 can beof constant or varying pitches. In various embodiments, the threadscould be v-form, square or acme threads, for example. FIG. 20illustrates an embodiment of the invention such that the threadedportions 152 c and 154 c that are used to secure the catch member 50 tothe tube does not extend the entire axial distance of the proximal end86 c. In another embodiment, the threaded portion does extend the entireaxial distance of the proximal end 86 c. In another embodiment, thethreaded portion extends the entire length of the catch member 50.

The embodiments and techniques described here are described preferablyfor use with a device made of a polymer and formed from a single tube.While the device is thus shown as being substantially formed from asingle tubular body, which could also be made of cylindrically arrangedfilaments, the catch mechanism as described in the embodiments abovecould be used with other types of devices, including those formed frommany pieces, and including devices formed from other materials,including metals, polymers, stainless steel or nitinol.

The term “bioabsorbable,” as used in the description above, is alsounderstood to mean “bioresorbable.”

While the description above refers to “wires”, and while the term “wire”might convey a more rigid piece than a string, a suture or a filament,all these terms are essentially interchangeable with respect to theinvention and any suitable element can be used. Each wire, string,suture and filament can be composed of one or more wires, strings,sutures and filaments.

In cases in which the device is made of a polymer, it can be desirableto add an additive or coating to the material to make it radiopaque tomake it more visible in a wider variety of imaging techniques.

It will be appreciated that while a particular sequence of steps hasbeen shown and described for purposes of explanation, the sequence maybe varied in certain respects, or the steps may be combined, while stillobtaining the desired deployment or in some cases to effect deploymentin a particular way. For example, the delivery sheath may be advanced orretracted at varying times and in varying degrees, the proximal anddistal portions of the occluder may be deployed into the petalconfiguration in a different sequence, etc. In addition, the steps couldbe automated.

It will be appreciated that the particular embodiments illustrated anddescribed herein are provided by way of example only and are notintended to limit the scope of the invention, which is indicated in theappended claims.

What is claimed is:
 1. A method for deploying a medical device having afirst, delivery configuration and a second, deployed configuration, toan aperture in the body comprising: introducing a delivery system,including the medical device, the medical device having a distal sideand a proximal side and a catch member, to a desired location in thebody, the catch member having a first external threads and the medicaldevice having a first internal threads; deploying a distal side of themedical device on a distal side of the aperture; deploying a proximalside of the medical device on a proximal side of the aperture; rotatingthe catch member relative to the medical device to cause the firstexternal threads disposed on the catch member to engage the firstinternal threads disposed on the medical device, whereby the medicaldevice is held in the second configuration; and releasing the medicaldevice from the delivery system.